Improved Diagnostics of Celiac Disease in Children

Study Purpose

The main purpose of this study is to improve the diagnostics of celiac disease and reduce the
need for invasive endoscopic studies in children. Further, the investigators aim to
investigate the natural history and risk of complications in children with celiac disease or
gluten sensitivity and to create a large scientific database.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Observational

Eligible Ages

N/A - 17 Years

Gender

All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Suspicion of celiac disease or gluten sensitivity
- Age below 18 years

Exclusion Criteria:

- Study refusal
- Age 18 years or more

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease, Eosinophilic Esophagitis

Additional Details

Prevalence of celiac disease is on a steep rise in Western countries, but due to difficult
diagnosis the majority of patients remain unrecognized. Undiagnosed celiac disease causes
incremental burden to the health care and predisposes to severe complications. On the other
hand, increasing screening in at-risk groups of celiac disease frequently detects
seropositive subjects with no obvious symptoms and/or still normal small-bowel mucosal
morphology. At present the natural history and benefits of an early diagnosis in such
individuals is poorly known. Further, the endoscopic demonstration of the small-intestinal
damage required for the diagnosis is unpleasant, expensive and often misleading. New
serology-based diagnostic criteria have been suggested but prospective data is lacking. Aims
of the present study are to improve the diagnostic yield and accuracy of the current
diagnostic methods and to develop novel non-invasive methods and biomarkers for early
detection of celiac disease. In addition, the investigators will evaluate natural history of
celiac disease in screening-detected asymptomatic children and in those with positive
serology but normal histology, and form a large database for future clinical and
translational studies. The study and patient collection are to be conducted at the pediatric
clinics in Finland and in Romania. All children referred due to suspicion of celiac disease
or gluten sensitivity will be asked to participate to the study. Patient samples and clinical
information are collected during the routine visits and the study does not include any
additional visits or endoscopies. The total duration of the study is 10 years but data will
be analyzed on-line.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tampere, Finland

Status

Recruiting

Address

Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital

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